Ketamine for MS Fatigue

Last updated: June 4, 2025
Sponsor: Alta Bates Summit Medical Center
Overall Status: Completed

Phase

1

Condition

Pain (Pediatric)

Memory Loss

Multiple Sclerosis

Treatment

ketamine

Clinical Study ID

NCT06064162
REDI2022MS
  • Ages 18-65
  • All Genders

Study Summary

The purpose of this study is to see whether using ketamine to increase glutamate in the prefrontal cortex can reduce Multiple Sclerosis (MS) related fatigue. The investigator proposes a prospective, crossover, randomized, placebo-controlled study to assess the efficacy and safety of low, single dose Ketamine, to assess its efficacy and safety in patients with MS-related fatigue.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Female and Male patients with any form of CDMS ages 18-65 inclusive

  2. Report fatigue which is interfering with QOL

  3. Able and willing to sign informed consent

  4. Stable on DMT for at least 3 months prior to baseline visit

  5. Not experiencing an MS relapse within 90 days prior to baseline visit.

  6. Must agree to practice an acceptable method of contraception

  7. Experiencing significant fatigue due to MS (MFIS of ≥10)

Exclusion

Exclusion Criteria:

  1. Allergy to Ketamine

  2. Taking medications which may interact with ketamine

  3. Change in DMT within 3 months prior to baseline visit

  4. MS relapse within 90 days of the baseline visit

  5. Confirmed diagnosis of untreated Sleep Apnea

  6. Confirmed diagnosis of periodic limb movement disorder

  7. Serious infection in the 30 days prior to baseline visit.

  8. Patients with significant comorbid conditions:

  9. Untreated hypertension (SBP>160, DBP>100 at baseline)

  10. Liver disease

  11. Significant renal disease

  12. History of cardiac arrhythmia

  13. Any comorbidities which at the opinion of the investigators post undue risk

  14. Current alcohol or drug abuse

  15. Participation in another interventional clinical trial in the past 3 months.

  16. Pregnant or lactating

  17. Any condition which in the opinion of the investigators will cause safety concernsfor the patient, or inability to comply with the protocol.

Study Design

Total Participants: 21
Treatment Group(s): 1
Primary Treatment: ketamine
Phase: 1
Study Start date:
December 05, 2023
Estimated Completion Date:
May 05, 2025

Study Description

The study treatment is designed in two 28-day cycles: for each cycle, participants will receive study infusion on Day 1 and complete follow-up visits during Days 7 and 28. Participants are randomized 1:1 to receive either ketamine (active treatment) or saline solution (placebo treatment) for their first infusion. They will not be blinded to their study assignment: the study doctor will disclose their assigned treatment group.

After their first infusion cycle, participents will crossover to the other treatment group. Worded differently, if a participant received ketamine during their first infusion, they will receive placebo treatment during their second infusion. Conversely, if a participant received saline treatment during their first infusion, they will receive ketamine during their second infusion.

Connect with a study center

  • Alta Bates Summit Medical Center

    Berkeley, California 94705
    United States

    Site Not Available

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